An EHR is HIPAA compliant only when the EHR system supports compliance with the HIPAA Security Rule and the HIPAA Privacy Rule through appropriate administrative, physical, and technical safeguards, the Covered Entity or Business Associate configures and uses the EHR to protect electronic protected health information, and the EHR vendor and any connected service providers that create, receive, maintain, or transmit electronic protected health information on the organization’s behalf will sign a HIPAA Business Associate agreement when they function as Business Associates.
HIPAA does not provide a government certification that makes an EHR compliant by default. Compliance depends on the EHR’s security and privacy features, the organization’s risk analysis and risk management decisions, and documented policies and procedures that govern access, use, disclosure, retention, and disposal of electronic protected health information.
The HIPAA Security Rule requires measures that protect the confidentiality, integrity, and availability of electronic protected health information and that guard against reasonably anticipated threats and impermissible uses or disclosures. An EHR used in regulated operations needs access controls that support unique user identification and role based access aligned to workforce duties, audit controls that record access and activity, authentication controls, and transmission security for data moving across networks. Encryption, backups, and availability controls support these requirements when implemented, monitored, and maintained as part of the organization’s security program.
The HIPAA Privacy Rule and the HIPAA Minimum Necessary Rule affect how the EHR is configured and used. Workforce access should be limited to the minimum necessary to perform assigned functions, and workflows should avoid unnecessary exposure of protected health information in scheduling, messaging, reporting, and shared work queues. Technical controls do not replace operational requirements such as workforce training, sanctions for improper access, and procedures for reviewing access logs and responding to suspected inappropriate activity.
Interoperability and third party connectivity affect HIPAA compliance scope. Interfaces to other systems, health information exchanges, patient portals, billing services, analytics platforms, and third party plug ins can introduce additional parties that handle electronic protected health information on behalf of the regulated entity. Each party that performs a function or service as a Business Associate requires a HIPAA Business Associate agreement, including subcontractors when applicable through downstream contracting. If an EHR vendor or connected provider will not sign a HIPAA Business Associate agreement when its services involve electronic protected health information, the service is not appropriate for regulated use involving that information.